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3. Regulatory and Approval Fees Isoflurane is subject to strict regulatory requirements imposed by health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The costs associated with obtaining and maintaining regulatory approvals, including clinical trials and post-market surveillance, are often reflected in the product’s price.
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The quality, purity, and efficacy of an API are vital to ensuring the safety and effectiveness of the final pharmaceutical product. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), impose stringent guidelines and standards for the production and testing of APIs. Manufacturers must comply with Good Manufacturing Practices (GMP), which outline the necessary controls and documentation to guarantee that APIs are consistently produced to quality standards.
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